Generic Name: tramadol (Oral route)
Tramadol hydrochloride has the potential for addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk before prescribing, and monitor for development of these behaviors or conditions. Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. Accidental ingestion of tramadol hydrochloride, especially in children, can result in fatal overdose of tramadol hydrochloride. Prolonged use of tramadol hydrochloride during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. Concomitant use or discontinuation of concomitantly used cytochrome P450 3A4 and cytochrome P450 2D6 inhibitors may effect the plasma levels of tramadol and its active metabolite M1 and lead to fatal respiratory depression, profound sedation, opioid toxicity, and/or opioid withdrawal. Monitor patients carefully when tramadol hydrochloride and cytochrome P450 3A4 and cytochrome P450 2D6 inhibitors are concurrently used. Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for patients with inadequate alternative treatment options. Limit dosages and durations to the minimum required and follow patients for signs and symptoms of respiratory depression and sedation .
Commonly used brand name(s)
In the U.S.
- FusePaq Synapryn
- Rybix ODT
- Ultram ER
Available Dosage Forms:
- Tablet, Extended Release
- Capsule, Extended Release
- Tablet, Disintegrating
Therapeutic Class: Analgesic
Chemical Class: Opioid
Uses For FusePaq Synapryn
Tramadol is used to relieve moderate to moderately severe pain, including pain after surgery. The extended-release or long-acting tablets are used for chronic ongoing pain.
Tramadol belongs to the group of medicines called opioid analgesics. It acts in the central nervous system (CNS) to relieve pain. When tramadol is used for a long time, it may become habit-forming (causing mental or physical dependence). Physical dependence may lead to side effects when you stop taking the medicine.
This medicine is available only with your doctor's prescription.
Before Using FusePaq Synapryn
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of Rybix™ ODT, Ryzolt™, and Ultram® tablets in children younger than 16 years of age. Safety and efficacy have not been established.
Appropriate studies have not been performed on the relationship of age to the effects of Ultram® ER extended-release tablets in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tramadol in the elderly. However, elderly patients are more likely to have unwanted side effects (eg, constipation, lightheadedness, dizziness, or fainting, stomach upset, weakness) and age-related liver, kidney, heart, or lung problems, which may require caution and an adjustment in the dose for patients receiving tramadol.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Interactions with Medicines
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Methylene Blue
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Chloral Hydrate
- Morphine Sulfate Liposome
- Nitrous Oxide
- Opium Alkaloids
- Peginterferon Alfa-2b
- Sodium Oxybate
- St John's Wort
- Tolonium Chloride
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Interactions with Food/Tobacco/Alcohol
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Alcohol abuse, history of or
- Brain tumor or
- Depression, history of or
- Drug abuse or dependence, history of or
- Gallstones or
- Head injury or
- Hormonal problems or
- Increased pressure in the head or
- Infections of the central nervous system (CNS) or
- Lung or breathing problems (eg, COPD, cor pulmonale, hypercapnia, hypoxia) or
- Mental illness, history of or
- Phenylketone allergy, history of or
- Seizures or epilepsy, history of or
- Stomach problems, severe—Use with caution. The chance of serious side effects may be increased.
- Breathing or lung problems (eg, asthma, hypercapnia, respiratory depression), severe or
- Stomach or bowel blockage (eg, paralytic ileus)—Should not be used in patients with this condition.
- Kidney disease or
- Liver disease (including cirrhosis)—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
- Phenylketonuria (PKU)—The orally disintegrating tablet contains phenylalanine, which can make this condition worse.
Proper Use of tramadol
This section provides information on the proper use of a number of products that contain tramadol. It may not be specific to FusePaq Synapryn. Please read with care.
Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.
If you think that this medicine is not working as well after you have been taking it for a few weeks, do not increase the dose. Instead, check with your doctor.
If you are using the disintegrating tablet, make sure your hands are dry before you handle the tablet. Do not open the blister pack that contains the tablet until you are ready to take it. Remove the tablet from the blister pack by peeling back the foil, then taking the tablet out. Do not push the tablet through the foil. Do not break, crush, or chew it. Place the tablet in your mouth. It should melt quickly. After the tablet has melted, swallow or take a sip of water.
Swallow the extended-release tablet and tabletwhole with liquids. Do not break, crush, or chew it.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For chronic pain:
- For oral dosage form (extended-release tablets):
- Adults—At first, 100 milligrams (mg) once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 300 mg per day.
- Children—Use and dose must be determined by your doctor.
- For oral dosage form (extended-release tablets):
- For moderate to severe pain:
- For oral dosage form (disintegrating tablets):
- Adults and children 16 years of age and older—At first, 50 to 100 milligrams (mg) every four to six hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 400 mg per day.
- Children younger than 16 years of age—Use and dose must be determined by your doctor.
- For oral dosage form (tablets):
- Adults and children 16 years of age and older—At first, 25 milligrams (mg) per day, taken every morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 400 mg per day.
- Children younger than 16 years of age—Use and dose must be determined by your doctor.
- For oral dosage form (disintegrating tablets):
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions While Using FusePaq Synapryn
It is very important that your doctor check your progress at regular visits to make sure the medicine is working properly and to check for any unwanted effects.
Do not use this medicine if you are using or have used an MAO inhibitor (eg, Eldepryl®, Marplan®, Nardil®, or Parnate®) within the past 14 days.
Check with your doctor before using this medicine with alcohol or other medicines that affect the central nervous system (CNS). The use of alcohol or other medicines that affect the CNS with (drug) may worsen the side effects of this medicine, such as dizziness, poor concentration, drowsiness, unusual dreams, and trouble with sleeping. Some examples of medicines that affect the CNS are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicines, medicine for depression, medicine for anxiety, prescription pain medicine or narcotics, medicine for attention deficit and hyperactivity disorder, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.
Using this medicine while you are pregnant may cause neonatal withdrawal syndrome in your newborn babies. Tell your doctor right away if your baby has an abnormal sleep pattern, diarrhea, a high-pitched cry, irritability, shakiness or tremors, weight loss, vomiting, or fails to gain weight.
Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.
This medicine can increase thoughts of suicide. Tell your doctor right away if you start to feel more depressed or have thoughts about hurting yourself. Report any unusual thoughts or behaviors that trouble you, especially if they are new or get worse quickly. Make sure your caregiver knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Tell your doctor if you have any sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. Let your doctor know if you or anyone in your family has bipolar disorder (manic-depressive disorder) or has tried to commit suicide.
This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, swelling of your hands, face, or mouth, or chest pain while you are using this medicine.
This medicine may cause some people to become drowsy, dizzy, lightheaded, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.
Make sure your doctor knows if you are pregnant, may be pregnant, or planning to become pregnant.
Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem.
Before having any kind of surgery (including dental surgery) or emergency treatment, tell the doctor or dentist in charge that you are taking this medicine. Taking tramadol together with medicines that are used during surgery or dental or emergency treatments may cause increased side effects.
If you think you or someone else may have taken an overdose of tramadol, get emergency help at once. Signs of an overdose include convulsions (seizures), difficult or troubled breathing, irregular, fast or slow, or shallow breathing, pale or blue lips, fingernails, or skin, pinpoint pupils of the eyes, or trouble breathing.
Do not stop suddenly taking this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent a possible worsening of your condition and reduce the possibility of withdrawal symptoms such as anxiety, diarrhea, headache, nausea, shivering, sweating, tremors, or trouble with sleeping.
Using too much of this medicine may cause infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.
FusePaq Synapryn Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:Less common or rare
- Abdominal or stomach fullness
- abnormal or decreased touch sensation
- blisters under the skin
- blood in the urine
- blood pressure increased
- blurred vision
- change in walking and balance
- chest pain or discomfort
- convulsions (seizures)
- darkened urine
- difficult urination
- dizziness or lightheadedness when getting up from a lying or sitting position
- fast heartbeat
- frequent urge to urinate
- gaseous abdominal or stomach pain
- irregular heartbeat
- loss of memory
- numbness and tingling of the face, fingers, or toes
- numbness, tingling, pain, or weakness in the hands or feet
- pain in the arms, legs, or lower back, especially pain in the calves or heels upon exertion
- pain or discomfort in the arms, jaw, back, or neck
- pains in the stomach, side, or abdomen, possibly radiating to the back
- pale bluish-colored or cold hands or feet
- recurrent fever
- seeing, hearing, or feeling things that are not there
- severe cramping
- severe nausea
- severe redness, swelling, and itching of the skin
- trembling and shaking of the hands or feet
- trouble performing routine tasks
- weak or absent pulses in the legs
- yellow eyes or skin
Get emergency help immediately if any of the following symptoms of overdose occur:Symptoms of overdose
- Change in consciousness
- decreased awareness or responsiveness
- difficulty with breathing
- lack of muscle tone
- loss of consciousness
- pinpointed pupils of the eyes
- severe sleepiness
- slow or irregular heartbeat
- unusual tiredness
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:More common
- Abdominal or stomach pain
- dry mouth
- feeling of warmth
- feeling sad or empty
- feeling unusually cold
- general feeling of discomfort or illness
- itching or skin rash
- joint pain
- loss of appetite
- loss of interest or pleasure
- loss of strength or weakness
- muscle aches and pains
- redness of the face, neck, arms, and occasionally, upper chest
- runny nose
- sleepiness or unusual drowsiness
- sore throat
- stuffy nose
- trouble concentrating
- unusual feeling of excitement
- Abnormal dreams
- appetite decreased
- back pain
- bladder pain
- blistering, crusting, irritation, itching, or reddening of the skin
- bloody or cloudy urine
- body aches or pain
- change in hearing
- cold flu-like symptoms
- cough producing mucus
- cracked, dry, or scaly skin
- decreased interest in sexual intercourse
- difficult, burning, or painful urination
- difficulty with moving
- disturbance in attention
- ear congestion
- ear drainage
- earache or pain in ear
- excessive gas
- false or unusual sense of well-being
- feeling hot
- feeling jittery
- flushing or redness of the skin
- general feeling of bodily discomfort
- headache, severe and throbbing
- hot flashes
- inability to have or keep an erection
- itching, pain, redness, swelling, tenderness, or warmth on the skin
- joint sprain
- joint stiffness
- joint swelling
- loss in sexual ability, desire, drive, or performance
- loss of voice
- lower back or side pain
- muscle aching or cramping
- muscle injury
- muscle pain or stiffness
- muscle spasms or twitching
- nasal congestion
- neck pain
- night sweats
- pain in the limbs
- pain or tenderness around the eyes and cheekbones
- pain, swelling, or redness in the joints
- skin discoloration
- swelling of the hands, ankles, feet, or lower legs
- tightness of the chest
- trouble in holding or releasing urine
- trouble with sleeping
- weight increased or decreased
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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